Zebinix Effectively Controls Epilepsy Seizures

Positive data from three phase III studies presented today at the American Epilepsy Society (AES) Congress, Seattle, USA, show that Zebinix (eslicarbazepine acetate), a novel once-daily anti-epileptic agent, significantly reduced the frequency of partial seizures and has the potential to significantly improve quality of life and depressive symptoms in patients with partial refractory epilepsy, in combination with other anti-epileptic agents.

Zebinix is one of the proposed EU trade names for eslicarbazepine acetate.

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Zebinix 800mg and 1200mg once-daily significantly reduced the frequency of partial seizures by over one third during the 12 week maintenance period of the studies.,,, In addition, new data presented for the first time at AES demonstrates that the reduction in seizure frequency was sustained over a one-year open-label treatment period. This sustained reduction over one year has now been demonstrated in all three phase III studies for Zebinix.,,

"The impact of epilepsy on quality of life and the development of depression cannot be underestimated. We must go beyond seizure control and ensure this is taken into consideration when assessing new treatments for epilepsy," said Joyce Cramer, research scientist at Yale University School of Medicine, USA and President of The Epilepsy Therapy Project. "During clinical studies, Zebinix has demonstrated that in addition to effective seizure control and good tolerability, it also provides significant improvement in quality of life and a reduction in depressive symptoms in long-term follow-up. Zebinix has the potential to become an important treatment option for patients with epilepsy who are not achieving seizure control with their existing medications."

Epilepsy is one of the most common neurological diseases affecting almost one in 100 people. Treatment of partial seizures, the most common type of epilepsy, presents a constant challenge with over half of patients not achieving adequate seizure control with current anti-epileptic drugs.

Zebinix, a new anti-epileptic drug that selectively inhibits the rapid firing of nerve cells that causes seizures, has been developed to address the need for a new anti-epileptic agent that offers a reduction in seizure frequency combined with a favourable tolerability profile. Zebinix is currently under review by the European Medicines Agency (EMEA) for the treatment of partial-onset seizures with or without secondary generalisation in combination with other anti-epileptic drugs. A U.S. New Drug Application (NDA) is currently being prepared with an anticipated submission to the U.S. Food and Drug Administration in early 2009.

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